The "Regulatory Affairs for Support Staff Training Course" training has been added to ResearchAndMarkets.com's offering.

Attend this interactive course to gain a valuable introduction to pharmaceutical regulatory affairs and key responsibilities, essential for those in support or interactive roles.

Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where an understanding of pharmaceutical regulatory affairs is important.

This interactive course is designed for professionals in support or interactive roles, offering a valuable introduction to pharmaceutical regulatory affairs and their key responsibilities.

Participants will gain an overview of current and proposed changes to EU legislation and regulatory procedures necessary to register products in the EU and the regulatory activities required to maintain products on the market. The UK is no longer a member of the EU but interactions and collaboration with the EU and other regulatory agencies for obtaining and maintaining marketing authorisations in the UK will be discussed.

This course aims to enhance understanding of the role of regulatory affairs, enabling support staff to perform more effectively and efficiently.

Interactive discussion sessions and practical case studies will help to consolidate learning, providing attendees with the skills and knowledge to be effective in their roles within the pharmaceutical industry.

Benefits of attending

• Understand the background of EU law - regulations, directives and guidelines
• Gain an understanding of the Common Technical Document
• Discuss how to apply for a marketing authorisation in the EU via the centralised, decentralised and mutual recognition procedures
• Clarify post-authorisation obligations - pharmacovigilance, variations and renewals
• Contribute to your Continuing Professional Development (CPD)

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Who Should Attend:

This course is designed for personnel wishing to gain an understanding of regulatory affairs in the pharmaceutical industry, including:

• Administrators
• Assistants
• Support Staff

Key Topics Covered:

Day 1

Current EU legislation

• Background
• Proposed changes to EU legislation
• The Internet
• Other sources

Drug Development

• Pharmaceutical R&D
• Non-clinical tests
• Clinical studies - Phase I to IV

Clinical trials in Europe

Seeking scientific advice in Europe

Marketing Authorisations

• Types of and categories for marketing authorisations

Overview of the structure and content of a CTD

Procedures for Marketing Authorisation in the EU

EU centralised procedures

• The EMA
• The Centralised Procedure (CP)
• Referral and arbitration

Day 2

Non-centralised procedures for marketing authorisation in the EU and in the UK

• Co-ordination Group
• Decentralised procedure (DCP)
• Mutual recognition procedure (MRP)
• National procedures
• Procedures in the UK

Abridged applications and generics

• Types and requirements

Product life cycle; post-approval

Parallel trade

Post-authorisation obligations

Pharmacovigilance

Licence variations

• Types and timelines

Extensions

Renewals

Sunset clause

Managing and supporting a regulatory affairs department

For more information about this training visit https://www.researchandmarkets.com/r/gca236

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